NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00169611|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1||Drug: methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo|
|Study Start Date :||January 2004|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
- Effect of methylphenidate compared to placebo on ADHD. Time of measurements are realised on day 0, day 28, day 63 + 2 days.
- To evaluate the efficacy of methylphenidate compared to placebo on specific neuropsychologic, depression and anxiety scales
- To compare the nature of attention deficit disorders in NF1 children with those with primary ADHD, depression, and anxiety using the State Trait Anxiety Inventory for Children (STAI-C) and the Children's Depression Inventory (CDI).
- Time of measurements are realised on day 0, day 28, day 63 + 2 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169611
|Lyon, France, 69005|
|Principal Investigator:||Laurence LION-FRANCOIS, MD||Service de Neuropédiatrie - Hôpital Femme Mère Enfant - Hospices Civils de Lyon - 59 bd Pinel - 69677 BRON - France|
|Principal Investigator:||Isabelle KEMLIN||Service de Neuropédiatrie - Hôpital Armand Trousseau - PARIS - France|